Process for preparing a nutraceutical beverage and a nutraceutical beverage

ABSTRACT

The present invention discloses a method of introducing a nutraceutical to a beverage comprising treating a beverage with a primary sterilizing agent, such as ozonation, filling a container with said beverage, adding an amount of a nutraceutical and sealing said container. The present invention allows for the production of a suitably sterile beverage without a substantial loss in the activity, or change in the structure, of a nutraceutical.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.10/286,345, filed Nov. 1, 2002, the entirety of which is incorporatedherein by reference.

BACKGROUND OF THE INVENTION

1. Field of Invention

The present invention relates to comestive drinks which are aqueousbased and incorporate a health-benefiting composition.

2. State of the Art

Current health drinks such as Gatorade®, a trademark of Stokely-VanCamp, Inc., and similar drinks are directed to providing electrolytesand other ingredients, which include caloric-providing compositions aswell. The art, however, is devoid of aqueous based drinks, which providea caloric neutral content while providing excellent hydration.

It is a well-established fact that being overweight and obese areunhealthy conditions. These conditions are associated not only withsocial stigma, but are also associated with decreased longevity andnumerous medical problems, such as diabetes, dermatological disorders,varicose veins, and heart disease. Perhaps in recognition of this, morepeople have begun to pay attention to what they eat, when they eat, howmuch they eat and proper exercise and hydration.

Existing therapies for people who are overweight, obese, or simply wishto remain fit, include treatments to establish a negative, or at leastneutral, energy balance. This may be accomplished by reduction of energyintake, such as a low calorie diet, or an increase in energyexpenditure, such as increased physical exercise. In addition,treatments include ingestion of sympathomimetic drugs which stimulatesthermogenesis, i.e. increases the metabolic rate. Known thermogenicdrugs include ephedrine, phenylpropanolamine, and caffeine. However,such drugs are rather ineffective and can have detrimental side-effects,some of which, e.g. ephedrine, may be very deleterious.

Over eating is also treated with drugs that suppress appetite by actingon the noradrenergic neurotransmitter, such as nazindol and derivativesof phenethylamine. Other treatments include the use of drugs whichaffect the serotonin neurotransmitter, such as fenfluramine, tryptophan,fluoxetine, and sertraline. However, all of these drugs have undesirableside effects.

In order to avoid such undesirable side effects, herbal compositionshave been used to promote weight loss. The herbal compositions arefrequently composed of one primary compound. Conventionally, thesecompositions are administered in a pill form to be taken orally. Toachieve a more encompassing approach to health, many such pills must betaken. Unfortunately, pills and/or capsules cannot be easily consumed ina discrete manner, are inconvenient, and many people have troubleswallowing pills and/or capsules.

In addition, maintaining a neutral or negative energy balance can leadto periodic or persistent sensations of hunger, making it difficult forpeople to control these sensations without consuming caloric-laden foodsor beverages. A person acting on such sensations will likely find itdifficult to maintain a neutral or negative energy balance. The resultis undesirable weight gain, or at least insufficient weight loss. Pasttreatments have offered nothing to curb the contemporary sensations ofhunger as a mechanism of suppressing appetite, instead focusing onfuture appetite suppression.

Currently most bottled water and many beverage manufactures utilizeozonation as a primary means of treating and sanitizing the beverage.Ozone is an excellent choice for this application due to thenon-selective oxidizing ability. Other treatments are known in the artincluding, chlorination, irradiation, ultraviolet light, heat, pHextremes, filtration and others. These treatments all pose a significantchallenge to the incorporation of a sensitive ingredient into theaqueous liquid in as much as degradation of a sensitive ingredient, fromoxidation or other treatments, would occur. Prior processes thereforelacked the ability to sanitize the liquid and its container whilemaintaining the integrity of sensitive ingredients such asnutraceuticals.

Manufacturers of bottled beverages have focused on sterilization of theproduct, for extended shelf life, as a single stage event, where all ofthe components of the beverage are assembled into an aqueous liquid andtreated so as to sterilize the beverage and the container into which itis placed. Because of the unified treatment the method of sterilizationmust be compatible with all of the individual ingredients andcomponents. This unified treatment results in challenging, and sometimesinsurmountable, barriers to the selection of an appropriate primarysterilization agent or method. Thus, current methods do not allow forthe suitably sterile introduction of sensitive components into a bottledbeverage that retains an acceptable shelf-stability. The presentinvention provides solutions to the above described problems.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to adding a nutraceutical to a containerafter introduction of a sterilized aqueous liquid and immediately priorto sealing the container. Nutraceuticals, which are health-relatedingredients of various types and may include pharmaceuticals, areexamples of substances that are desirable to introduce into packagedbeverages for a variety of purposes. The present invention allowsnutraceuticals, and other sensitive materials, to be introduced into thebeverage while retaining sterility and minimizing loss of activity.

In one embodiment the nutraceutical is prepared as an at least partiallysterile shelf-stable syrup. In another embodiment, a shelf-stable syrupcontaining a nutraceutical is added to an aqueous liquid in a containerprior to sealing the container.

In another embodiment the nutraceutical is added to an aqueous liquidfilled container, wherein the aqueous liquid has been previously treatedwith a primary sterilizing agent, e.g. ozone.

In another embodiment the nutraceutical is added post filling of thecontainer with ozonated water.

In another embodiment a method of adding a nutraceutical to an aqueousliquid to form a shelf-stable beverage comprising treating said aqueousliquid with a primary sterilizing agent, filling a container with saidaqueous liquid, adding said nutraceutical and sealing said container isprovided.

In another embodiment a method of adding a nutraceutical to an aqueousliquid to form a shelf-stable beverage is provided. The method comprisesozonating at least a part of said aqueous liquid to form an ozonatedaqueous liquid, providing a container having an internal volume at leastequal to a nutraceutical volume and an aqueous liquid volume, saidcontainer including a sealable opening communicating with said internalvolume, adding said ozonated aqueous liquid to said container in theamount of said aqueous liquid volume, adding a nutraceutical to saidcontainer in the amount of said nutraceutical volume and sealing saidsealable opening of said container.

The present invention relates to the addition of a nutraceutical to anaqueous liquid without degradation of the nutraceutical. The end productof such a process is a beverage enhanced with a nutraceutical in asuitably sterile, shelf-stable, container or package. The presentinvention provides a method of adding a nutraceutical to an aqueousliquid to form a shelf-stable beverage comprising treating said aqueousliquid with a primary sterilizing agent, filling a container with saidtreated aqueous liquid, adding said nutraceutical to said container andsealing said container.

The present invention also relates to compositions, particularly inbeverage form, for diminishing the appetite, reducing body fat andimproving lean body mass to improve health, and to provideanti-depressant effects while causing weight reduction.

An embodiment of the present invention provides a nutraceutical in aconsumable beverage, preferably a low or non-caloric beverage, e.g.,water, that additionally promotes effective re-hydration so that it canbe safely and efficiently consumed while engaging in an exerciseactivity. Such a beverage can be consumed discretely, easily, andwithout the difficulties associated with pills and/or capsules. Thisembodiment also provides a beverage which may help to suppress thesensations of hunger for a period of time substantially sufficient toallow the nutraceutical to take effect.

In another embodiment the present invention provides a combination ofnutraceutical capable of effective appetite suppression and additionalhealth benefits such as decreased body fat, an improved intestinal faunaand anti-depressant effects.

In another embodiment, the present invention provides a nutraceuticalcomprising an effective amount of forskohlin, hydroxycitric acid orsalts thereof and fructooligosaccharides.

In another embodiment, the present invention provides a nutraceuticalcontaining beverage comprising an effective amount of forskohlin, aneffective amount of hydroxycitric acid or salts thereof, an effectiveamount of fructooligosaccharides and an aqueous liquid suitable forconsumption by a human or animal.

In aother embodiment, the nutraceutical is added to produce a beveragecomprising non-flavored water. The composition was selected to providethe perceived health benefits without adversely affecting the perceivedtaste, color or clarity of water. Therefore, the composition plus waterhas the taste and appearance of water. In one embodiment of anon-flavored water Forskohlin is added to a final concentration of about100 mg/L (±10%), Hydroxycitric acid and/or CITRIN® is added to a finalconcentration of about 300 mg/L (±10%), and fructo-oligosaccharides areadded to a final concentration of about 1 g/L (±10%). In this embodimentthe ratio of Forskohlin to Hydroxycitric acid is about 1:3 and the ratioof Forskohlin to fructo-oligosaccharides is about 1:10. Where desiredand appropriate, other products having no perceived effect on the taste,color or clarity of the water may be added. Thus, the composition isformulated to allow the nutraceutical plus water to retain the clarity,taste, appearance, and re-hydration properties of purified water, whilehaving the benefit of the added composition.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned features and advantages of this invention, andothers related thereto, as well as the manner of attaining them, willbecome more apparent and the invention will be better understood byreference to the following description of an embodiment of the inventiontaken in conjunction with the accompanying drawing, wherein:

FIG. 1 is a flow chart showing an embodiment of the invention.

The exemplification set out herein illustrates one embodiment of theinvention, in one form, and such exemplification is not to be construedas limiting the scope of the invention in any manner.

DETAILED DESCRIPTION OF THE INVENTION

As used herein the term aqueous liquid means any liquid having asignificant water content. The aqueous liquid may contain additionalingredients without deviating from the meaning of aqueous liquid as usedherein.

As used herein the term beverage means a consumer ready productcomprising any liquid intended for human or animal consumption.

As used herein the term bottled or bottling means a beverage introducedor being introduced into any suitable container. The phrase bottledbeverage is used merely as an example of one type of container.

As used herein the term brix means a hydrometer scale for solutionsindicating the percentage by weight of a dissolved solid or by volume ofan added liquid.

As used herein the term container means any suitable packaging apparatusincluding, but not limited to, glass and plastic bottles, glass andplastic jars, liquid compatible paper cartons, metal cans and drums, orany other receptacle fit for the retention of aqueous liquid. Containersmay be of any appropriate or desirable size.

As used herein the term nutraceutical means a natural or synthesizedsubstance that provides at least a perceived health or medical benefit.

The terms “primary sterilizing agent” and “supplemental sterilizingagent” or “secondary sterilizing agent” do not refer to a temporalrelationship. Rather, the primary sterilizing agent refers to asubstantial participation in the production of a shelf-stable beveragefilled container. When the beverage is non-flavored purified water, thetaste and clarity of purified water are retained.

As used herein the term sterilizing agent means a substance having aneffect on product safety, stability and shelf-life, including anantiseptic effect.

As used herein the term weight or dry weight means the mass of asubstance, or a group of substances each of which is a subset of the setdefined by the substance name, times the magnitude of the accelerationdue to gravity, as determined for the substance in any powdered state.

The present invention relates to the addition of a nutraceutical to anaqueous liquid without degradation of the nutraceutical. The end productof such a process is a beverage enhanced with a nutraceutical in asuitably sterile, shelf-stable, container or package. The presentinvention provides a method of adding a nutraceutical to an aqueousliquid to form a shelf-stable beverage comprising treating said aqueousliquid with a primary sterilizing agent, filling a container with saidtreated aqueous liquid, adding said nutraceutical to said container andsealing said container.

To minimize the degradation of the nutraceutical, the nutraceutical ispreferably administered post filling of the container and immediatelyprior to sealing. In one example of the present invention, ozone, astrong sterilizing agent, but one which has a short half-life, is usedas the primary sterilizing agent to obtain the oxidative action of ozoneon the aqueous liquid and packaging material wherein the addition of thenutraceutical is delayed to minimize the oxidative effect on thenutraceutical.

A nutraceutical may be composed of any compound, or combinationsthereof, so as to produce a perceived beneficial effect. Examples ofsuch compounds include, but are not limited to;7β-acetoxy-8,13-epoxy-1α,6β,9 9α-trihydroxylabd-14-en11-one, Forskholin(see U.S. Pat. No. 5,804,596, sold under the trademark FORSLEAN®),hydroxycitric acid and salts thereof (see U.S. Pat. No. 5,783,603, soldunder the trademark CITRIN®-K), fructooligosaccharides (such as thosesold under the trademark NUTRAFLORA®), glucomanan, chromium picolinate,garcinia cambogia, garcinia cambogia, chitosan, steroidal glycosides,Gymnema Sylvestre; Kola Nut; Citrus Aurantium; Yerba Mate; GriffoniaSimplicifolia, guar gum, a plant extract derived from the groupcomprising the genus Trichocaulon and the genus Hoodia and havingappetite suppressant activity,3-0-[-β-D-thevetopyranosyl-(1→4)-β-D-cymaropyranosyl-(1→4)-β-D-cymaropyranosyl]-12β-0-tigloyloxy-14-hydroxy-14β-pregn-50-en-20-one(C₄₇H₇₄O₁₅M⁺878) (See European Patent application EP 1 222 927), anyherb, any herb extract, and any pharmaceutical. The nutraceutical formedwith an effective amount of one or more of above may be combined withadditional nutraceuticals, pharmaceuticals, carriers, or otheringredients to produce a desired benefit or to produce multiple orcombinatorial benefits. Examples of other ingredients include, but arenot limited to, vitamins, natural and artificial flavors, electrolytes,dietary fiber, calcium, iron, zinc, calcium disodium EDTA, citric acid,CO₂ or any other desired ingredient.

Without being bound by any theory, a fructooligosaccharide, includingshort-chain fructooligosaccharides, is a prebiotic found in many fruits,vegetables and grains. However, the amount of fructooligosaccharidesfound in fruits, vegetables and grains frequently render it impracticalfor a person to consume enough biomass of the fruits, vegetables andgrains to effectively achieve the desired health benefits. The presentinvention may utilize an effective amount of fructooligosaccharidesprepared in a more concentrated form to achieve the desired healthrelated result. Literature related to the health benefits offructooligosaccharides include: Hidaka, et al., Effects ofFructooligosaccharides on Intestinal Flora and Human Health,Bifidobacteria Microflora, 5(1), 37-50, (1986); Buddington, et al.,Dietary supplement of neosugar alters the fecal flora and decreasesactivities of some reductive enzymes in human subjects, American Journalof Clinical Nutrition, 63:709-716, (1996); Alm, The effect ofLactobacillus acidophilus administration upon the survival of Salmonellain randomly selected human carriers, Progress in food and NutritionScience, 7:13-17, 1983; and Buddington et al., Am. J. Clin. Nutr. 63:709-16, (1996).

Without being bound by any theory, Forskolin,deacetylforskolin,9-deoxyforskolin, 1,9-deoxyforskolin,1,9-dideoxy-7-deacetylforskolin are diterpenoid compounds, which arereported in U.S. Pat. No. 5,804,596 to activate adenylate cyclase toreduce body fat and restore monoamine levels to provide ananti-depressant effect. See Tandon, J. S. et al., Ind. J. Chem.,15B:880-883 (1977); Gabetta. B., et al., Minor diterpenoids of Coleusforskohlii Phytochemistry, 28(3):859-862 (1989); Okuda H, et al.,Relationship between cyclic AMP production and lipolysis induced byforskolin in rat fat cells, J Lipid Res, 33(2):225-31 (1992).

Potassium hydroxycitrate is reported in U.S. Pat. No. 5,783,603 todecrease body weight by increasing the body's consumption of fat anddecreasing the liver's s rate of gluconeogenesis.

Chromium picolinate is an organic compound of trivalent chromium andpicolinate acid, reported in the literature to possess fat burningproperties.

Garcinia cambogia is an herbal component which is reported to inhibitlipogenesis, lower the production of cholesterol and fatty acids,increase the production of glycogen in the liver thereby suppressingappetite, and increasing the body's production of heat by activating theprocess of thermogenesis.

Glucomanan is a natural dietary, calorie-free, high fiber powder,obtained from the root of amorphophallus konjac, with the reportedproperty of being an appetite suppressant due to the fact that it mayabsorb up to fifty times its weight in liquid.

Guar gum, otherwise known as Cyamopsis Tetragonoloba, is a water solublepolymer extracted from guar seeds. Guar gum has found use in slimmingaids, nutritional foods, and water soluble dietary fiber formulations.Guar gum, a galactomannan polysaccharide, and other gel-forming fiberssuch as psyllium hydrophilic mucilloid, have been recognized to have atherapeutic value for lowering cholesterol and helping to regulate bloodsugar. The cholesterol-lowering properties of guar gum and othermucilaginous substances were initially recognized by Fahrenbach et al.(U.S. Pat. No. 3,148,144).

Chitosan is a fiber composed of chitin, which is a component of theexoskeleton of shellfish. Without being bound by any theory, chitin maybe processed so that it has a high binding, that is, absorption,affinity for fat and cholesterol within the digestive tract. Fibers suchas chitosan prepared so as to have high binding affinity are reported toabsorb many times their weight of fat and cholesterol.

Forskohlin is reported to be insoluble in water. The present inventionuses an advanced water soluble formulation of forskohlin. The watersolubility allows the present invention to combine the fat burningpotential of forskohlin with the appetite suppression of Hydroxycitricacid and the carbohydrate uptake inhibition of fructoologosaccharides.The combined effect of Forskohlin, Hydroxycitric acid andfructoologosaccharides provides a nutraceutical with significant impacton body mass. The novel combination of ingredients provides amultifaceted approach to weight reduction not found in similar products.

Forskohlin, as a liquid or solid, may be mixed with Hydroxycitric acidand/or CITRIN®, as a liquid or solid, by any method so as to produce aratio of Forskohlin to Hydroxycitric acid. The ratio of Forskohlin toHydroxycitric acid can be varied from 5:1 to 1:80, including about 1:1,about 1:3, about 1:4 and about 1:10. One embodiment utilizes a ratio ofabout one gram of Forskohlin to about 3 grams of Hydroxycitric acidand/or CITRIN®. Forskohlin, as a liquid or solid, may be mixed withfructo-oligosaccharides, as a liquid or solid, by any method so as toproduce a ratio of Forskohlin to fructo-oligosaccharides. The ratio ofForskohlin to fructo-oligosaccharides can be varied from 2:1 to 1:200,including about 1:1, about 1:4 and about 1:15. One embodiment utilizes aratio of about one gram of Forskohlin to about 10 grams offructo-oligosaccharides. Hydroxycitric acid, as a liquid or solid, maybe mixed with fructo-oligosaccharides, as a liquid or solid, by anymethod so as to produce a ratio of Hydroxycitric acid tofructo-oligosaccharides. The ratio of Hydroxycitric acid tofructo-oligosaccharides can be varied from 8:1 to 1:50, including about1:3, about 1:2, about 1:5. The ratios expressed in this paragraphreflect the relative dry weights of the compounds. The compounds may bemixed at any point in time. For example, the compounds may be premixedin dry form and stored for later use.

An effective amount is a quantity of one or more of the compoundswherein an average adult would experience the health benefits of thecompounds. The health benefits include appetite suppression, effectingthe intestinal flora, promotion of lean body mass, anti-depressanteffects and reduced body fat.

An aqueous liquid is prepared by methods known in the art and processedsuch that it is substantially prepared for bottling. The aqueous liquidmay contain any other ingredients so as to produce a desired benefit,flavor or effect. Examples of other ingredients include, but are notlimited to, vitamins, natural and artificial flavors, electrolytes,dietary fiber, calcium, iron, zinc, calcium disodium EDTA, citric acid,CO₂ or any other desired ingredient. The aqueous liquid is treated witha primary sterilizing agent including, but not limited to, filtration,ozonation, chlorination, peroxide treatment, treatment with Ultravioletlight, irradiation, pH extremes, dimethyl dicarbonate (sold under thetrademark VELCORIN®, see U.S. Pat. No.), K-sorbate and/or Na-benzoatewith ascorbic acid and dimethyl dicarbonate (see U.S. Pat. No.5,866,182) or other known antiseptic or sterilizing agents or methods.

In another embodiment an effective amount of a supplemental or secondarysterilizing agent is added to the aqueous liquid or nutraceutical tofurther reduce or inhibit undesirable products, including, but notlimited to, fungal, bacterial, and other microorganisms. Thesupplemental sterilizing agent may be added to the aqueous liquid priorto treatment with ozone or at any time prior to sealing of thecontainer. The supplemental sterilizing agent preferably does notsubstantially adversely affect the activity of the nutraceutical oraffect the desired taste and flavor of the beverage. Examples ofsupplemental sterilizing agents include, but are not limited to, variousorganic and inorganic copper compounds, e.g.; cupric acetate, cupriccitrate, cupric gluconate, cupric glycinate, cupric sulfate, cuproussulfate, cuprous oxide, chelates of copper, and the like, as well asiron and zinc compounds such as, ferric hydroxide, iron salts, zincacetate, zinc carbonate, zinc chloride, zinc citrate, zinc permanganate,dimethyl dicarbonate (sold under the trademark VELCORIN®, see U.S. Pat.No.), K-sorbate and/or Na-benzoate with ascorbic acid and dimethyldicarbonate (see U.S. Pat. No. 5,866,182), quinolone carboxylic acids(see U.S. Pat. No. 4,559,341), or any other appropriate preservative.Addition of a supplemental or secondary sterilizing agent reduces thesterilization demand on the primary sterilizing agent, for example,allowing use of the primary sterilizing agent at lower concentrations.

The nutraceutical maybe added to the beverage or aqueous liquid filledcontainer by any method known in the art. Preferably, the nutraceuticalis added to the beverage filled container by a peristaltic pump or othermetering dispensing device, which allows for a measured quantity of thenutraceutical to be added to each container. Such measuring device maybe constructed so as to minimize exposure of the concentrate and theaqueous liquid filled container to possible contamination.

Sufficient nutraceutical may be added to an aqueous liquid filledcontainer to achieve the desired final concentration, for example,0.002%, or 0.5 ml/L. The amount of the nutraceutical to be added, so asto achieve the desired final concentration in the beverage (the“dosage”), is mathematically related to the initial concentration of thenutraceutical and the desired dosage. The amount of nutraceuticalrequired to achieve the desired dosage in the final product can becalculated by standard methods known in the art.

Changes in pH, produced by CO₂ or other ingredients, may result inchanges to the color and flavor of the beverage. For example, additionof carbon dioxide to an aqueous liquid results in a decrease in the pHof the liquid. It is known in the art that pH can produce perceivedflavors. For example, a strongly basic solution may result in theperception of a “salty” taste. Where appropriate and desirable the pH ofthe nutraceutical or beverage maybe adjusted so as to produce an asepticproduct. Where the beverage is primarily water, significant changes inthe pH may result in undesirable changes to the flavor of the beverage.

Addition of the primary sterilizing agent, preferably ozone, to theaqueous liquid is accomplished by any of the methods and apparatus knownin the art. The primary sterilizing agent serves to appropriatelysterilize the aqueous liquid and receiving container at the time offilling. In addition, the primary sterilizing agent preferably does notsufficiently adversely affect the perceived flavor and appearance of thebeverage. Preferably the sterilizing agent retains sufficient activityto sterilize the sealing mechanism. Even more preferably, thesterilizing agent does not retain sufficient activity to detrimentallyaffect the structure or activity of the nutraceutical following sealingof the container.

The effect of the sterilizing agent may be assayed by methods known inthe art. For example, High pressure liquid chromatograph (HPLC) may beused to assay for loss of structure. Comparison of the peak area priorto treatment and after sterilization allows for the calculation of loss.Alternatively, functional assays may be performed to determine loss ofactivity.

When the primary sterilizing agent is ozonation, ozone may be added to aconcentration of about 0.01 to 3 mg/L of aqueous liquid. Preferably,ozone is added to an initial concentration of about 0.1 to 1 mg/L, morepreferably 0.2 to 0.4 mg/L. Ozone may be added to any desiredconcentration so as to achieve the desired results. The duration andamount (intensity, etc.) of primary sterilizing agent necessary toachieve the desired sterilization in any particular aqueous liquid,without significant loss to the nutraceutical's activity, may bedetermined by methods and procedures including HPLC, TLC, ion exchangechromatography, size exclusion, bioassays, or the like. Secondary orsupplemental sterilizing agents may be added to such that the durationand amount of the primary sterilizing agent may be reduced.

A nutraceutical syrup, powder, solution or liquid maybe prepared and/orutilized in either a batch process or a continuous process. As will berecognized by a person of ordinary skill in the art addition of drycompounds and other formulations may be utilized in any combinationdesired. Where the dry compounds or composition are dissolve in aliquid, this process may be augmented by methods known in the art,including heating, physical agitation, or the like.

The purified water, or the aqueous liquid, may be treated with a primarysterilizing agent, such as ozonation. Ozone is added to the pre-chilledbeverage at a dose of about 0.2-3 mg/L or about 0.2-0.4 mg/L. Thetemperature of the beverage at the time of addition of the ozone affectsthe duration of oxidative activity. Preferably, the ozone is added to abeverage that has been cooled to a temperature of 10° C. or less.Addition of ozone at higher temperatures results in increased loss ofthe ozone to the surrounding atmosphere. At temperatures above 10° C.ozone is lost to the atmosphere at a rate exponentially related to thetemperature. Thus, the temperature of the beverage at the time ofozonation will affect the appropriate handling time. Addition of 0.2-0.4mg/L of ozone to an aqueous liquid, chilled to a temperature of about10° C., yields an ozonated aqueous liquid which will continue toliberate sufficient ozone for several minutes. Adding the ozonatedaqueous liquid to a container within this time allows the liberatedozone to improve sterilization of the containers head space.

Addition of nutraceuticals to an aqueous liquid provides a deliveryvehicle for the nutraceuticals, which include pharmaceuticals and thelike, wherein absorption is increased. Furthermore, binders common tomany powdered formulations are eliminated, thereby speeding absorptionby the body. Addition of nutraceuticals to an aqueous liquid can, undersome conditions can significantly increase the effect of thenutraceutical. Moreover, hydration combined with the medical or healthbenefits of the nutraceutical provide the nutraceutical to the body in asimple and effective solution. Addition of nutraceuticals to anon-flavored aqueous liquid, e.g. purified water, provides thenutraceuticals in a pleasant to drink formulation that lacks caloriccontent and undesirable flavors. Providing a nutraceutical or medicationin a non-flavored aqueous liquid form, e.g. purified water, provides aneffective method of presenting formulations that in the past have beenassociated with undesirable flavors or tastes.

Following the addition of the nutraceutical and aqueous liquid, thecontainer is sealed using methods known in the art. The container may besealed so as to ensure continued sterility and/or to protect the productfrom alteration or contamination and/or to prevent gaseous exchange,hermetically sealed.

The final aqueous liquid or beverage preferably has no perceivedoff-flavors or undesirable coloration. Off-flavors comprise flavors thatare undesirable in the final product. This may be based on customerperception or marketing strategy. When the final aqueous liquid is anon-flavored bottled water product the final product preferably shouldhave no detectable flavor other than that of water and has no detectablecolor or particulate material.

The sealed container may then be stored, consumed immediately or furthertreated. For example, such further treatments include, but are notlimited to; pasteurization, irradiation, refrigeration, Ultravioletlight treatment or the application of heat at least sufficient tothermally stress microorganisms.

EXAMPLE 1

Forskohlin, Hydroxycitric acid and Fructooligosaccharides are added to aliquid medium, which is partially composed of water, to a finalconcentration of 67 to 75 Brix by weight to form a syrup as in FIG.1(1). The Forskohlin, Hydroxycitric acid and Fructooligosaccharidesmaybe added in a ratio of three grams of Hydroxycitric acid for everygram of Forskohlin and ten grams of Fructooligosaccharides for everygram of Forskohlin. The syrup is then heated to a temperature between138° C. and 145° C., using a heat exchanger constructed in a shell andtube design with reverse flow, for a period of about 2 to 8 seconds asin FIG. 1(2), to produce a shelf-stable syrup as contemplated in FIG.1(3). Other suitable methods for heating the syrup to similar uniformtemperatures may be utilized.

A Brix concentration of about 67 or greater results in a syrup that isnaturally resistant to microbial growth. The additional heat treatmentresults in additional sterility and an increase in the shelf-life. Oneof the benefits derived from the heat treatment of the syrup is thegeneration of a concentrated nutraceutical liquid composition that canbe stored. In addition, the concentrated nutraceutical syrup, when addedlater to a beverage filled container, does not result in undesirablemicrobial contamination. Addition of a microbial load contained in thesyrup would require additional primary sterilizing activity to counterthe increased load. Increased primary sterilizing activity remainingafter the addition of the nutraceutical would result in increaseddegradation of the nutraceutical. Thus, the heat treatment provides abenefit that can be readily utilized where desirable and appropriate.

Forming a shelf-stable nutraceutical containing syrup permits the syrupto be prepared in one location, then shipped to a second location forfurther processing into a shelf-stable nutraceutical containingbeverage.

Purified water, as contemplated in FIG. 1(A), may be, but is not limitedto, natural spring water or purified water. Purified water is known inthe art, and usually generated by deionization followed by filtration orreverse osmosis. In one embodiment, purified water is utilized so as toreduce the dissolved solid content and to prevent precipitation ofvarious salts.

A supplemental sterilizing agent, such as minimal, but effective,quantities of a copper salt, may be added to the purified water ascontemplated in FIG. 1(B). A supplemental sterilizing agent such as acopper salt or the like is generally either a bacteriostat, whichinhibits microbial growth, or a bacteriocide. Thus, addition of thesupplemental sterilizing agent prevents or slows the growth of anymicroorganism within the product. One aspect of the secondarysterilizing agent is to prevent the growth of spores or other sources ofmicrobial growth that escape sanitization by the primary sterilizingagent.

The aqueous liquid may then be treated with a primary sterilizing agent,such as ozonation, as contemplated in FIG. 1(C). Ozone is added to thepre-chilled beverage at a dose of about 0.2-0.4 mg/L. The temperature ofthe aqueous liquid at the time of addition of the ozone affects theduration of oxidative activity. Preferably, the ozone is added to abeverage that has been cooled to a temperature of 10° C. or less.Addition of ozone at higher temperatures also results in increased lossof the ozone to the surrounding atmosphere. Thus, the temperature of thebeverage at the time of ozonation will affect the time allowable foraddition of the nutraceutical and sealing of the container.

The ozonated aqueous liquid is then added to an appropriate container ascontemplated in FIG. 1(D). Following the addition of the ozonatedaqueous liquid, the nutraceutical, preferably in the form of ashelf-stable syrup, is added to the ozonated aqueous liquid filledcontainer, for example between FIGS. 1(D) and (E). The container is thensealed and can be further packaged and/or treated in preparation forshipment. See FIG. 1(F).

The time from addition of the ozonated aqueous liquid to a container,through the process of adding the nutraceutical, to the sealing of thepackage may be referred to as the handling time. Where appropriate anddesirable the handling time most effective for a given set of conditionsmay be altered by changing the amount of the primary sterilizing agent,the temperature of the beverage, the dissolved solid content of thebeverage or the like.

If criteria exist requiring any dilution in effect of residual ozone onthe nutraceutical composition, an appropriate amount of a strongantioxidant such as vitamin C (as ascorbic acid) or vitamin E(α-tocopherol) or the like can be added to neutralize any excessresidual ozone or free oxygen. Such antioxidants not only rapidly reactwith oxygen, but are generally considered as healthy nutritionalsupplements. It may be desirable to allow a small amount of residualozone to remain in the beverage to continue its sanitizing effect.

The present invention results in the production of a sterile productwithout any significant loss of nutraceutical activity that has beenassociated with processes which include addition of a sensitiveingredient to a beverage prior to treatment with ozone. Addition of asufficiently shelf-stable nutraceutical syrup after addition of theozonated beverage to the container results in sterilization of thecontainer and sufficient residual ozone (oxidative activity) tosterilize the sealing mechanism and any previously exposed surfaces.However, there is not sufficient ozone activity to substantially reducethe activity, or change the structure, of the nutraceutical.

Addition of a nutraceutical requires an effective method of dissolving,stabilizing, adding, and maintaining the integrity of the ingredientsused to fortify the finished product. One preferred embodiment utilizesa syrup concentrate inhospitable to microbial growth having thenutraceutical therein. See FIG. 1(1). The syrup may be treated by way ofhigh heat processing, for example to increase product safety and shelfstability. See FIG. 1(2). Development of a nutraceutical syrupconcentrate also enables, at the bottling stage, a greater ease ofincorporation that is both uniform and accurate relative to properdosage levels in the finished product.

EXAMPLE 2

A supplemental sterilizing agent, such as a copper salt, maybe added tothe aqueous liquid of Example 1. A supplemental sterilizing agent suchas a copper salt or the like is either a bacteriostat, which inhibitsmicrobial growth, or a bacterioside. Thus, addition of the supplementalsterilizing agent prevents or slows the growth of any organism withinthe product. One aspect of the secondary sterilizing agent is to preventthe growth of spores or other sources of microbial growth that escapethe primary sterilizing agent. Addition of a supplemental or secondarysterilizing agent, such as a copper salt, reduces the amount of primarysterilizing agent necessary to produce a shelf-stable aqueous beverage.Spores or microorganisms surviving the primary sterilizing agent areinhibited or killed by the secondary sterilizing agent, which is addedto the beverage in an amount effective to prevent or inhibit themicroorganisms.

In this embodiment, the nutraceutical activity is further preserved bythe toxic effect of the copper ions on potential microorganisms. Inaddition, the copper ions provide a nutritional factor to humans andanimals. Addition of an effective amount of a copper salt, such ascupric sulfate, cuprobam, cuprous iodide, or the like, reduces thenecessary concentration of primary sterilizing agent. For example,addition of copper in a range of about 0.25 to about 0.5 mg/L providessufficient sterilizing activity to allow the use of ozone in a range ofabout 0.2 to about 0.4 mg/L during a cold filling process. This processallows for the production of a shelf-stable beverage, with minimaldegradation to the sensitive nutraceuticals.

To produce a nutraceutical concentrate or syrup, at least onenutraceutical is added to a liquid medium up to a concentration of about45 to 95 Brix, preferably about 60-80 Brix, more preferably about 65-75Brix, and most preferably about 67 Brix, hereinafter the “syrup.” Wheredesirable and appropriate, the syrup is treated by high heat processing,wherein the syrup is heated to a temperature above 100° C., morepreferably between 130 and 150° C., or even more preferably between 138to 145° C. for a sufficient time to achieve a substantially uniformtemperature throughout the syrup. The temperature should be sufficientto kill or shock undesirable microorganisms without adversely affectingthe nutraceutical. Where desirable and appropriate, the syrup is heatedfor a period of between about 0.1 to about 300 seconds, more preferably,about 2 to about 8 seconds and most preferably about 2 seconds. Heatingof the syrup maybe accomplished by any methods known to a person ofskill in the art, for example, by use of a heat exchange such as a shelland tube design with a reverse flow. A shelf-stable syrup that ispreferably aseptic and poses minimal contamination risk for subsequentprocessing is achieved by this method.

Syrups of about 85 Brix or greater may result in increased viscosity ofthe syrup. The increase in viscosity may affect pumping and thetime/temperature relationship of the heat treatment. The increasedviscosity may be addressed by use of alternative pumping systems knownin the art, such as a systolic pump. The time/temperature relationshiprequired to produce the desired shelf-stable syrup maybe adjusted asappropriate and desirable. Factors to be considered include themicrobial load of the finished product, the microbial load of theresultant syrup, the dissolved solids content of the syrup, heat damageto the compounds comprising the syrup, and changes in color and taste.

The shelf-stable syrup may be produced and used at the same location, orproduced in one location and shipped to the bottling facility in adifferent location. In addition, shipment of a concentrated syrup isconsiderably more economical than shipping the finished beverage longdistances. The shelf-stable syrup subjected to high temperatureprocessing may remain sterile for up to 18 months. Without the formationof a concentrated syrup, with or without high temperature processingmaintenance of sterility is impractical at best.

EXAMPLE 3

In another embodiment, at least one nutraceutical is prepared as asterile powder. The powder may be introduced into the aqueous liquid inpowdered form. Alternatively, the nutraceutical may be preparedinitially in a separate liquid and introduced into the aqueous liquid orused to produce the syrup. To produce the syrup starting with one ormore nutraceuticals in liquid form, the nutraceutical may beconcentrated by methods known in the art prior to addition to the fluidmedium, or, where appropriate, the liquid nutraceutical may be theinitial liquid medium to which additional nutraceuticals are added whereappropriate and desirable.

All references, including publications, patents, and patentapplications, cited herein are hereby incorporated by reference to thesame extent as if each reference were individually and specificallyindicated to be incorporated by reference and were set forth in itsentirety herein.

While this invention has been described in certain embodiments, thepresent invention can be further modified within the spirit and scope ofthis disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains and which fallwithin the limits of the appended claims.

1. A method of making a shelf-stable nutraceutical-containing aqueousliquid comprising: treating an aqueous liquid with a primary sterilizingagent; adding said aqueous liquid to a container; adding saidnutraceutical to said aqueous liquid; and sealing said container.
 2. Themethod of claim 1, wherein said aqueous liquid is chilled prior toadding it to said container.
 3. The method of claim 1, wherein saidnutraceutical is added to said aqueous liquid immediately prior tosealing said container.
 4. The method of claim 1, wherein saidnutraceutical is a liquid shelf-stable syrup.
 5. The method of claim 1,further comprising adding a supplemental sterilizing agent to saidaqueous liquid or said container.
 6. A method of adding a nutraceuticalto an aqueous liquid to form a shelf-stable beverage comprising:ozonating at least a part of said aqueous liquid to form an ozonatedaqueous liquid; providing a container having an internal volume at leastequal to a pre-selected nutraceutical amount and a pre-selected aqueousliquid amount, said container including a sealable opening communicatingwith said internal volume; adding said ozonated pre-selected aqueousliquid amount to said container; adding said pre-selected nutraceuticalamount to said container; and sealing said sealable opening of saidcontainer.
 7. The method of claim 6, wherein said nutraceutical is aliquid, shelf-stable syrup.
 8. The method of claim 6, further comprisingadding a supplemental sterilizing agent to said aqueous liquid or tosaid container.
 9. The method according to claim 6, wherein saidnutraceutical is added to said container immediately prior to sealingsaid container.
 10. The method of claim 6, wherein the oxidativeactivity of ozone remaining as such in said aqueous liquid is at leastpartly reduced prior to adding a nutraceutical.
 11. The method accordingto claim 7, further comprising heating said liquid shelf-stable syrup toa temperature between about 138° C. and about 145° C., wherein saidheating is done before adding said nutraceutical to said container. 12.The method according to claim 7, wherein said nutraceutical comprises apre-selected amount of a nutraceutical selected from the groupconsisting of Forskohlin, hydroxycitric acid, salts thereof, orfructooligosaccharides.
 13. The method according to claim 12, whereinsaid shelf-stable syrup comprises a solution having a dissolved solidcompound content sufficient to produce a hydrometer reading of betweenabout 60 and about 80 brix.
 14. The method according to claim 12,wherein said shelf-stable syrup comprises a solution having a dissolvedsolid compound content sufficient to produce a hydrometer reading ofbetween about 65 and about 75 brix.
 15. The method according to claim 6,wherein said ozonated aqueous liquid is chilled prior to adding ozoneand having an ozone concentration in said ozonated aqueous liquidbetween about 0.2 and about 0.4 mg/L.
 16. The method according to claim15, wherein said nutraceutical comprises a shelf-stable syrup having adissolved solid content between about 65 and about 75 brix.
 17. Themethod according to claim 16, further comprising heating saidshelf-stable syrup to a temperature between about 138° C. and about 145°C., wherein said heating is done before adding said nutraceutical tosaid container in the amount of said nutraceutical volume.
 18. Themethod according to claim 17, further comprising adding a supplementalsterilizing agent having a copper compound, and wherein said aqueousliquid comprises purified water.
 19. The method according to claim 18,wherein said shelf-stable syrup comprises Forskohlin, hydroxycitricacid, and salts thereof, and fructooligosaccharides, present in a finalamount having a ratio of said forskohlin to said hydroxycitric acid, andsalts thereof, of about 1:1 to about 1:3, and a ratio of said forskohlinto said fructooligosaccharides of about 1:1 to about 1:10.
 20. Themethod according to claim 6, wherein said nutruceutical comprisesForskohlin, hydroxycitric acid, and salts thereof, andfructooligosaccharides, present in a final amount having a ratio of saidforskohlin to said hydroxycitric acid, and salts thereof, of about 1:1to about 1:3, and a ratio of said forskohlin to saidfructooligosaccharides of about 1:1 to about 1:10.
 21. The methodaccording to claim 8, wherein said ozonated aqueous liquid is chilledprior to adding ozone and having an ozone concentration in said ozonatedaqueous liquid between about 0.2 and about 0.4 mg/L.
 22. A nutraceuticalbeverage produced by the process comprising: forming a nutraceuticalcomprising Forskohlin, hydroxycitric acid, and salts thereof, andfructooligosaccharides, wherein a weight of forskohlin to a weight ofsaid hydroxycitric acid, and salts thereof, is a ratio of about 1 toabout 3, and wherein a weight of said forskohlin to a weight of saidfructooligosaccharides is in a ratio of about 1 to about 10; forming ashelf-stable syrup, wherein said Forskohlin, hydroxycitric acid, andsalts thereof, and fructooligosaccharides are introduced into water toform said shelf-stable syrup having a dissolved solid content betweenabout 65 and about 75 brix by weight; heating said shelf-stable syrup toa temperature between about 138° C. and about 145° C. for between about2 and about 8 seconds; ozonating at least a part of a purified water toform an ozonated purified water having a dissolved ozone concentrationbetween about 0.2 and about 0.4 mg/L; providing a container having aninternal volume at least equal to a nutraceutical volume and a purifiedwater volume, said container including a sealable opening communicatingwith said internal volume; adding said ozonated purified water to saidcontainer in the amount of said purified water volume; adding saidshelf-stable syrup to said container in the amount of said nutraceuticalvolume; adding a supplemental sterilizing agent having about 0.25 toabout 0.5 mg/L copper to a volume selected from the group consisting ofsaid nutraceutical volume and said purified water volume; and sealingsaid sealable opening of said container, thereby providing a purifiedwater.
 23. The nutraceutical according to claim 21, wherein saidpurified water comprises a final Forskohlin concentration of about 100mg/L, a final hydroxycitric acid, and salts thereof, concentration ofabout 300 mg/L and a final fructooligosaccharides concentration of about1 g/L.